NCT06219694 Laser Acupuncture for Chronic Migraine

Trial Parameters

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Brief Summary

A single-blind randomized controlled trial was conducted from October 2024 to May 2025. Chronic migraine patients were randomly assigned in a 1:1 ratio to receive either Laser acupuncture or sham treatment. The co-primary outcomes were changes in monthly migraine days (MMD) and acute headache medications usage days per month from baseline, and Hospital Anxiety and Depression Scale (HADS), and Beck's Depression Inventory(BDI) evaluation. Evaluations were taken at baseline and each follow-up point. After \>6 months follow up as washing out time, the sham group received complementary laser acupuncture treatment and follow up for another 3 months, compared the Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle).

Eligibility Criteria

Inclusion Criteria: * patients aged above 20 years old and had CM managed pharmacologically, including preventive and/or acute migraine medications, and in addition, those who had refused preventive agent despite recommendation of the neurologist; * patients who had unsatisfactory effect of current pharmacological treatments, defined as they self-reported * patients who had a minimum of one-year history of migraine with or without aura. Exclusion Criteria: * patients who had received another LA therapy or traditional acupuncture at baseline * migraine onset after the age of 50 * cognitive or psychological impairment interfering with the participant's ability to receive LA protocol and describe symptoms * patients with missing data at baseline or during the follow-up period.

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